NCT01406392

Brief Summary

The purpose of this study is to compare effectiveness and safety of a sublingual misoprostol 12,5 mcg with vaginal misoprostol 25 mcg for induction of labour with an alive and term fetus.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Jul 2014

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 29, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 1, 2011

Completed
2.9 years until next milestone

Study Start

First participant enrolled

July 1, 2014

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2016

Completed
Last Updated

September 18, 2019

Status Verified

September 1, 2019

Enrollment Period

2.4 years

First QC Date

July 29, 2011

Last Update Submit

September 15, 2019

Conditions

LaborInduced

Keywords

MisoprostolSublingualInducedLabor

Outcome Measures

Primary Outcomes (1)

  • Frequency of taquissistoly

    during 48 hours the presence of taquissistoly will be observed

    48 hours

Secondary Outcomes (18)

  • Hyperstimulation Syndrome

    48 hours

  • changes in the cervix at 12 and 24 hours

    12 and 24 hours

  • failure to achieve vaginal delivery within 12 and 24 hours

    12 and 24 hours

  • the mother's preferred route of administration

    after 48 hours

  • time between the first dose and the onset of labour and delivery

    after 48 hours

  • +13 more secondary outcomes

Study Arms (2)

Sublingual Misoprostol 12,5mcg

ACTIVE COMPARATOR

Sublingual misoprostol or placebo tablete will be administered for each six hours until the maximum dose of 100mcg or eight tablets.

Drug: Sublingual Misoprostol

Vaginal Misoprostol 25 mcg

ACTIVE COMPARATOR

Vaginal misoprostol or placebo tablets will be administered for each six hours until the maximum dose of 200mcg or eight tablets. Each pacient will receve at the same time a sublingual placebo tablet and vaginal misoprostol or sublingual misoprostol and vaginal placebo tablet. It will depend of the randomization.

Drug: Misoprostol 25mcg

Interventions

Misoprostol 25mcgDRUG

Vaginal misoprostol or placebo tablets will be administered for each six hours until the maximum dose of 200mcg or eight tablets.

Also known as: Prostokos Cytotec
Vaginal Misoprostol 25 mcg
Sublingual MisoprostolDRUG

Sublingual misoprostol or placebo tablets will be administered for each six hours until the maximum dose of 100mcg or eight tablets

Also known as: Prostokos, Cytotec
Sublingual Misoprostol 12,5mcg

Eligibility Criteria

Age15 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Indication for labour induction
  • Term pregnancy with alive fetus
  • Bishop score less than six

You may not qualify if:

  • Previous uterine scar
  • Nonvertex presentation
  • Non-reassuring fetal status
  • Fetal anomalies
  • Fetal growth restriction
  • Genital bleeding
  • Tumors, malformations and/or ulcers of vulva, perineum or vagina

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Instituto de Medicina Integral Professor Fernando Figueira (IMIP)

Recife, Pernambuco, 50070-550, Brazil

Location

Related Publications (2)

  • Gattas DSMB, de Amorim MMR, Feitosa FEL, da Silva-Junior JR, Ribeiro LCG, Souza GFA, Souza ASR. Misoprostol administered sublingually at a dose of 12.5 mug versus vaginally at a dose of 25 mug for the induction of full-term labor: a randomized controlled trial. Reprod Health. 2020 Apr 10;17(1):47. doi: 10.1186/s12978-020-0901-8.

    PMID: 32272959DERIVED

  • Gattas DSMB, da Silva Junior JR, Souza ASR, Feitosa FE, de Amorim MMR. Misoprostol administered sublingually at a dose of 12.5 mug versus vaginally at a dose of 25 mug for the induction of full-term labor: a randomized controlled trial protocol. Reprod Health. 2018 Apr 18;15(1):65. doi: 10.1186/s12978-018-0508-5.

    PMID: 29669596DERIVED

MeSH Terms

Interventions

Misoprostol

Intervention Hierarchy (Ancestors)

Prostaglandins E, SyntheticProstaglandins, SyntheticProstaglandinsEicosanoidsFatty Acids, UnsaturatedFatty AcidsLipidsAutacoidsInflammation MediatorsBiological Factors

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

July 29, 2011

First Posted

August 1, 2011

Study Start

July 1, 2014

Primary Completion

November 30, 2016

Study Completion

November 30, 2016

Last Updated

September 18, 2019

Record last verified: 2019-09

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL
Time Frame
After publication in scientific journal

Locations

BR(1)